For Healthcare Professionals

Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)

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About the study

This is a randomized, multi-center, double-blind, placebo-controlled, global, Phase III study to determine the efficacy and safety of durvalumab + Chemoradiotherapy versus Chemoradiotherapy alone as treatment in Women With Locally Advanced Cervical Cancer
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

For inclusion in the study, patients should fulfill the following criteria:

  1. Female
  2. Aged at least 18 years
  3. Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO (2009) Stages IB2 to IIB node positive or FIGO (2009) IIIA-IVA any node
  4. No prior chemotherapy or radiotherapy for cervical cancer
  5. WHO/ECOG performance status of 0-1
  6. At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion at baseline.

EXCLUSION CRITERIA

Patients should not enter the study if any of the following exclusion criteria are fulfilled:

  1. Diagnosis of small cell (neuroendocrine) histology or mucinous adenocarcinoma cervical cancer
  2. Intent to administer a fertility-sparing treatment regimen
  3. Undergone a previous hysterectomy
  4. Evidence of metastatic disease per RECIST 1.1 including lymph nodes ≥15 mm (short axis) above the L1 cephalad body, in the inguinal region or outside the planned radiation field.
  5. History of allogeneic organ transplantation
  6. Active or prior documented autoimmune or inflammatory disorders
  7. Uncontrolled intercurrent illness
  8. History of another primary malignancy and active primary immunodeficiency
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-877-240-9479Email iconEmail Study Center

Study’s details


Contition

Locally Advanced Cervical Cancer

Age

18+

Phase

Phase 3

Participants needed

770

Est. Completion Date

Jun 2023

Treatment type

Interventional


Sponsor

AstraZeneca

ClinicalTrials.gov identifier

NCT03830866

Study number

D9100C00001

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